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Children Of Thalidomide

Children Of Thalidomide

thalidomide

Thalidomide, sold under the brand name Immunoprin, among others, is an immunomodulatory drug and the prototype of the thalidomide class of drugs. Today, thalidomide is used mainly as a treatment of certain cancers (multiple myeloma) and of a complication of leprosy.

Thalidomide was first marketed in 1957 in West Germany under the trade name Contergan. The German drug company Chemie Grünenthal developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure "anxiety, insomnia, gastritis, and tension".[3] Afterwards, it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over-the-counter drug in West Germany on October 1, 1957. Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived.[4] Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived. Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness.

The story of thalidomide, told in this week’s Retro Report video, is one of the most shameful in the history of the modern pharmaceutical industry.

In the 1950s, a German company, Chemie Grünenthal, developed thalidomide, which was marketed in Europe as the first safe sleeping pill and was seen as a highly effective treatment for pregnant women with morning sickness.

The drug enjoyed such widespread success that in some European countries it became almost as popular as aspirin.

But thalidomide was far from safe. Although the cause was not realized until later, the first known victim of thalidomide was a girl born with no ears on Christmas Day in 1956 — a daughter of a Grünenthal employee.

In time, thousands of children around the world whose mothers took the drug while pregnant were born with severe physical disabilities, including flipper-like arms and legs. The archival footage of these children in the Retro video is both horrifying and heartbreaking, as are the stories of the many families who were devastated and unable to cope.

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Thalidomide-affected children were in some instances rejected by their parents and institutionalized. Others had their flippers amputated to accommodate prostheses for arms and legs. In one extreme case, a young mother and her doctor were charged with the mercy killing of her deformed infant.

But in the United States things were different, thanks to one of those little known heroes who simply did her job well, and in the process, prevented the drug from being approved.

In September 1960, Dr. Frances Oldham Kelsey, a young pharmacologist who had just started working at the Food and Drug Administration, was asked to review the drug for approval but became alarmed by what she saw as the lack of rigorous scientific research supporting the drug’s safety done by Grünenthal and William S. Merrell, the United States distributor.

Once she examined the research carefully, the case for thalidomide quickly unraveled. She kept asking the company for more data, delaying approval. In late November 1961, long-ignored evidence became public in Germany linking thalidomide to birth defects. Grünenthal, which in a court case years later blamed causes like nuclear fallout or botched home abortions for the children’s deformities, did not apologize to the victims and their families until last year.

Because of Dr. Kelsey’s perseverance, the drug never received F.D.A. approval and in 1962, the drug was banned worldwide. But almost as important, it marked the beginning of a new era for the F.D.A.

Major regulatory reforms were finally forced on the pharmaceutical industry, many of the same federal guidelines that we live under today.

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